The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: Trial nasal mask (F&P)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of OSA by Physician
- ≥ 22 years of age
- ≥ 66 lbs
- Prescribed PAP or BPAP therapy for OSA
- Existing nasal, sub-nasal and pillows mask users
- Fluent in written and spoken English
Exclusion Criteria:
- Inability to give informed consent
- Pregnant or think they may be pregnant
- PAP Intolerant
- Anatomical or Physiological Conditions that make PAP inappropriate
- IPAP pressure of ≤25cmH20.
- PAP/BPAP therapy device without data recording capabilities
- Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Sites / Locations
- Clayton Sleep Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Experimental trial nasal mask
Arm Description
Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.
Outcomes
Primary Outcome Measures
Number of Participants Objective Trial Mask Performance
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device.
Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask.
Secondary Outcome Measures
Number of Participants Trial Mask Overall Simplicity of Use
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value.
Number of Participants Subjective Trial Mask Comfort
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages.
Number of Participants Overall Trial Mask Satisfaction
Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ).
Full Information
NCT ID
NCT04011826
First Posted
July 2, 2019
Last Updated
November 29, 2021
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04011826
Brief Title
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official Title
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed Description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After a period of baseline, all enrolled participants will be put on the same trial mask.
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Experimental trial nasal mask
Arm Type
Experimental
Arm Description
Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.
Intervention Type
Device
Intervention Name(s)
Device: Trial nasal mask (F&P)
Other Intervention Name(s)
New nasal mask
Intervention Description
This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
Primary Outcome Measure Information:
Title
Number of Participants Objective Trial Mask Performance
Description
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device.
Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask.
Time Frame
14 ± 3 days in home
Secondary Outcome Measure Information:
Title
Number of Participants Trial Mask Overall Simplicity of Use
Description
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value.
Time Frame
14 ± 3 days in home
Title
Number of Participants Subjective Trial Mask Comfort
Description
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages.
Time Frame
14 ± 3 days in home
Title
Number of Participants Overall Trial Mask Satisfaction
Description
Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ).
Time Frame
14 ± 3 days in home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of OSA by Physician
≥ 22 years of age
≥ 66 lbs
Prescribed PAP or BPAP therapy for OSA
Existing nasal, sub-nasal and pillows mask users
Fluent in written and spoken English
Exclusion Criteria:
Inability to give informed consent
Pregnant or think they may be pregnant
PAP Intolerant
Anatomical or Physiological Conditions that make PAP inappropriate
IPAP pressure of ≤25cmH20.
PAP/BPAP therapy device without data recording capabilities
Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Muehlbach
Organizational Affiliation
Clinical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with any other researchers or organizations.
Learn more about this trial
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
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